Deflectable guide catheters and related methods

ABSTRACT

Deflectable guide catheters and methods, including methods for using defectable guide catheters to perform transnasal procedures within the ear, nose, throat, paranasal sinuses or cranium. Some deflectable guide catheters of the present invention comprise a substantially rigid tube, a helical spring attached to and extending from the distal end of the substantially rigid tube, a tubular plastic inner jacket, an outer plastic jacket substantially covering at least the helical spring member. The spring member is deflectable to cause the distal portion of the guide catheter to deflect to a curved configuration. In embodiments for transnasal use the deflectable guide catheter may have a length of less than 25 cm.

RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No. 16/212,864, entitled “Deflectable Guide Catheters and Related Methods,” filed on Dec. 7, 2018, which is a continuation of U.S. patent application Ser. No. 11/804,308, entitled “Deflectable Guide Catheters and Related Methods,” filed on May 16, 2007, issued as U.S. Pat. No. 10,188,413 on Jan. 29, 2019, which is a continuation in part of the following U.S. patent applications: (1) Ser. No. 11/037,548 filed Jan. 18, 2005, issued as U.S. Pat. No. 7,462,175 on Dec. 9, 2008, which is a continuation in part of Ser. No. 10/829,917 filed Apr. 21, 2004, issued as U.S. Pat. No. 7,654,997 on Feb. 2, 2010; (2) Ser. No. 11/150,847 filed Jun. 10, 2005, issued as U.S. Pat. No. 7,803,150 on Sep. 28, 2010, which is a continuation in part of Ser. No. 10/944,270 filed Sep. 17, 2004, published as U.S. Pub. No. 2006/0004323 on Jan. 5, 2006, now abandoned, which is a continuation in part of Ser. No. 10/829,917 filed Apr. 21, 2004, issued as U.S. Pat. No. 7,654,997 on Feb. 2, 2010; (3) Ser. No. 11/193,020 filed Jul. 29, 2005, published as U.S. Pub. No. 2006/0063973 on Mar. 23, 2006, now abandoned, which is a continuation in part of Ser. No. 10/944,270 filed Sep. 17, 2004, published as U.S. Pub. No. 2006/0004323 on Jan. 5, 2006, now abandoned, which is a continuation in part of Ser. No. 10/829,917 filed Apr. 21, 2004, issued as U.S. Pat. No. 7,654,997 on Feb. 2, 2010; and (4) Ser. No. 11/436,892 filed May 17, 2006, published as U.S. Pub. No. 2007/0208252 on Sep. 6, 2004, now abandoned, which is a continuation in part of (a) Ser. No. 11/116,118 filed Apr. 26, 2005, issued as U.S. Pat. No. 7,720,521 on May 18, 2010, which is a continuation in part of Ser. No. 10/829,917 filed Ap. 21, 2004, issued as U.S. Pat. No. 7,654,997 on Feb. 2, 2010, (b) Ser. No. 10/912,578 filed Aug. 4, 2004, issued as U.S. Pat. No. 7,361,168 on Apr. 22, 2008, (c) Ser. No. 10/944,270 filed Sep. 17, 2004, published as U.S. Pub. No. 2006/0004323 on Jan. 5, 2006, now abandoned, and (d) Ser. No. 11/037,548 filed Jan. 18, 2005, issued as U.S. Pat. No. 7,462,175 on Dec. 9, 2008, the entire disclosure of each such application (except U.S. patent application Ser. No. 11/804,308) being expressly incorporated herein by reference.

FIELD OF THE INVENTION

The present invention relates generally to medical apparatus and methods and more particularly to deflectable guide catheters and their methods of manufacture and use.

BACKGROUND OF THE INVENTION

U.S. Pat. No. 5,562,619 (Mirarchi, et al.) describes a deflectable catheter that may be inserted percutaneously and advanced through the vasculature to access the heart or brain. An elongated wound wire coil extends through a hollow catheter body, such coil being constructed and arranged to enable the catheter body to withstand reactive compressive load without distortion during application of tension on the pull wire and to transmit torque from the proximal to the distal tip portion of the catheter to enhance fidelity of rotational positioning of the distal tip in response to rotational orientation of the proximal portion of the catheter. The coil is in frictional torque-transmitting relationship with the interior of the hollow shaft substantially along the common length of the catheter body when the catheter is bent. This deflectable catheter purportedly has augmented throw for one-handed operation.

U.S. Pat. No. 6,755,812 (Peterson et al.) describes a deflectable, telescoping guide catheter having an inner guide with a pre-formed distal tip, an outer guide with a predetermined deflection location, and a proximal actuator. The inner guide can be longitudinally extended and axially rotated relative to the outer guide. The proximal actuator can adjustably change a bend angle of the predetermined deflection location. The catheter can be deployed with the inner guide retracted inside the distal end of the outer catheter. The extensible and rotatable inner catheter can be combined with the adjustable bend angle of the outer guide to provide an improved system for accessing and cannulation of venous structures.

U.S. Pat. No. 5,195,168 (Lundquist, et al.) describes a steering mechanism for use in a variety of medical catheters. Such steering mechanism includes a steering shaft coupled to a controller which manipulates the distal end of the steering shaft. The steering shaft includes a flexible coiled spring having a lead spring fixed in position with respect to a distal end thereof in the distal end of the steering shaft. The distal ends of one or more steering wires is/are affixed to the lead spring. The steering wires extend through the steering shaft to the controller, and the steering apparatus of the controller is used to place tension on the steering wire(s). The attachment of the distal ends of the steering wires to the lead spring may be opposite one another or may be offset for providing greater maneuverability. Tension may be placed on the steering wires by wedges mounted transversely to the controller housing, or by rotation of a shaft mounted transversely to the controller housing, the steering wires being attached to the shaft such that rotation in one direction tenses one steering sire, and rotation in the other direction tenses the other steering wire. Two independently rotatable shafts may be used to separately control the two steering wires. The steering shaft is adapted for insertion into a lumen of a catheter for use in guiding the distal end of the catheter to a treatment site within a patient. The steering mechanism may also be used in conjunction with tools or apparatus which must reach into difficult locations, such as engines or other machines.

U.S. Pat. No. 5,733,248 (Adams et al.) describes a universal guide catheter that has a shaping mandrel inserted into a lumen of the catheter. The shaping mandrel changes from a first configuration to a second configuration after the catheter has been inserted into the body. In some embodiments the shaping mandrel is formed of a shape memory material which changes from the first shape to the second shape as the catheter warms to body temperature.

U.S. Pat. No. 6,585,717 (Wittenberger et al.) describes a deflection mechanism for a medical device comprising a plurality of rings and a connecting structure connecting the plurality of rings. This deflection mechanism is purportedly that are positionable in a catheter or other flexible body to cause a distal portion of the catheter or other flexible body to deflect or curve in more than one direction in a single plane and/or in more than one plane and/or to be deflected more than 360 degrees to form a loop.

U.S. Pat. No. 6,890,329 (Carroll et al.) describes another deflection mechanism that is purportedly capable of deflecting portions of a catheter or other flexible body in more than one direction in a single plane and/or in more than one plane and/or in a curve of more than 360 degrees to form a loop.

Also, Mols, B., Moveable Tool Tip for Keyhole Surgery, Delft Outlook, Vol. 3, Pages 13-17 (2005), describes a moveable tip which incorporates a spring and one or more pull cables to facilitate deflection or steering of the tip of the device before or after insertion into a patient's body during keyhole (e.g., laparoscopic) surgery.

Additionally, Piers et al., A Flexible Distal Tip With Two Degrees of Freedom for Enhanced Dexterity in Endoscopic Robot Surgery, Proceedings 13th Micromechanics Europe Workshop, Pages 271-74 (2002) describes a flexible tube that can be bent by pulling cables running along its length. An outer tube formed on NiTi alloy is disposed on a distal portion of the flexible tube and is cut into a series of rings connected by thin elastic joints.

Also, a number of deflectable guide catheters are on sale and in public use, including for example, the Morph™ Vascular Access Catheter (BioCardia, South San Francisco, Calif.) which is intended to serve as a conduit for access in the coronary vasculature and chambers of the heart and the Attain® Deflectable Catheter Delivery System (Medtronic, Inc., Minneapolis, Minn.) which is intended for use in coronary sinus cannulation and delivery of electronic pacing leads.

Recently, a transnasal, catheter-based procedure has been developed for treating sinusitus and other disorders of the ear, nose throat and paranasal sinuses (Balloon Sinuplasty™ Procedure; Acclarent, Inc., Menlo Park, Calif.). In this procedure, an appropriately shaped guide catheter having a fixed distal curve is selected from a series of available guide catheter shapes, and the selected guide catheter is advanced though a nostril to a position where the distal end of the guide catheter is adjacent to the ostium of a paranasal sinus. A guidewire is ten advanced through the guide catheter and into the paranasal sinus. Thereafter, a balloon catheter is advanced over the guidewire and through the guide catheter, to a position where the balloon is within the ostium of the paranasal sinus. The balloon is then inflated causing enlargement and restructuring of the ostium, thereby improving sinus drainage. At present, the sinus guide catheters are commercially available in a variety of fixed shapes having distal curves from 0 degrees to 110 degrees (Relieva° Sinus Guide Catheters, Acclarent, Inc., Menlo Park, Calif.). The surgeon typically selects a sinus guide catheter which has a fixed distal curve that is believed to be best for accessing a particular sinus ostium. The fixed distal; curvature of the selected sinus guise catheter cannot be changed while the guide catheter is inserted in the subject's nose.

U.S. patent application Ser. No. 11/037,548, issued as U.S. Pat. No. 7,462,175 on Dec. 9, 2008; Ser. No. 11/150,847, issued as U.S. Pat. No. 7,803,150 on Sep. 28, 2010; Ser. No. 11/193,020, published as U.S. Pub. No. 2006/0063973, now abandoned; and Ser. No. 11/436,892, published as U.S. Pub. No. 2007/0208252 on Sep. 6, 2004, now abandoned, of which this application is a continuation in part, describe the use of deflectable or steerable guide catheters in the performance of the Balloon Sinuplasty™ procedure as well as various other procedures wherein deflectable or steerable guide catheters are used to guide devices (e.g., guidewires, catheters, implantable drug delivery devices, etc.) to desired locations within the ear, nose, throat or cranium.

There remains a need for further development of new deflectable guide catheters having variable shapes and their methods of manufacture and use for transnasal and/or other applications.

SUMMARY OF THE INVENTION

In accordance with the present invention, there is provided a method for delivering a substance or device (e.g., a guidewire, catheter, implant or any other diagnostic or therapeutic device) to a desired location within the ear, nose, throat or cranium of a human or animal subject using a deflectable guide catheter that has an elongate catheter shaft, a distal portion of the shaft which is deflectable, a distal end and a deflection control that remains outside of the subject's body and is useable to cause the distal portion of the shaft to deflect form a first configuration to a second configuration. Such method generally includes the steps of (A) inserting the guide catheter, distal end first, through a nostril of the subject, (B) using the deflection control to deflect the distal portion of the catheter shaft from the first configuration to the second configuration, (C) positioning the distal end at or near the desired location; and (D) advancing a device or delivering a substance or flow of energy through the guide catheter and to or through the desired location.

Further in accordance with the present invention, there are provided deflectable guide catheter devices that are useable to perform the above summarized method as well as other methods wherein it is desired to deliver a substance or device (e.g., a guidewire, catheter, implant or any other diagnostic or therapeutic device) to a desired location anywhere within the body of a human or animal subject. In general, these guide catheter devices of the present invention comprise (A) a substantially rigid tube (e.g., a metal hypotube) having a lumen, an inner surface, an outer surface and a distal end, (B) a deflectable member (e.g., a spring member) having a distal end, said helical spring member being attached to and extending from the distal end of the substantially rigid tube, (C) a tubular plastic inner jacket having an inner surface, an outer surface and a lumen, said inner jacket extending through the lumen of the metal outer tube and through the helical spring member; (D) an outer jacket (e.g., a separate tube, sheath or coating) substantially covering at least the deflectable member and (E) a deflector member extending between the inner surface of the substantially rigid tube and the outer surface of the tubular inner jacket, said deflector member being attached to the helical spring member at or near its distal end such that, when the deflector member is pushed or pulled, a distal portion of the guide catheter will deflect. In embodiments intended for delivering devices or substances transnasally to locations within the ear, nose, throat or cranium of a human or animal subject, the deflectable guide catheter device may have a length of less than approximately 25 cm and in some embodiments less than 15 cm.

Still further in accordance with the present invention, there are provided other deflectable guide catheter devices and methods of use. These other deflectable guide catheter devices generally comprise a tubular catheter shaft that includes a proximal segment having a beveled distal end and a distal segment having a beveled proximal end that abuts against the beveled distal end of the proximal segment. The distal segment is rotatable between a) a first position where the beveled proximal end of the distal segment abuts with the beveled distal end of the proximal segment in a manner that causes the catheter shaft to be substantially straight and b) a second position wherein the beveled proximal end of the distal segment abuts with the beveled distal end of the proximal segment in a manner that causes the catheter shaft to be curved. Also, in some embodiments, such deflectable guide catheter device may further include a medial segment disposed between the proximal and distal segments. Such medial segment has a beveled proximal end and a beveled distal end. The beveled proximal end of the medial segment abuts against the beveled distal end of the proximal segment and the beveled distal end of the medial segment abuts against the beveled proximal end of the distal segment. In this embodiment, the medial and distal segments are independently rotatable to impart different curvatures to the catheter shaft. In operation, the medial and/or distal segments are rotated to provide a desired curvature of the catheter shaft prior to or after insertion of the catheter shaft into the body of a human or animal subject.

Further aspects, elements and advantages of the present invention will be understood by those of skill in the art upon reading of the detailed description set forth herebelow.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a side view of one embodiment of a deflectable guide catheter device of the present invention.

FIG. 1A is a transverse sectional view through line 1A-1A of FIG. 1.

FIG. 1B is a partial longitudinal sectional view through line 1B-1B of FIG. 1.

FIG. 1C is a partial longitudinal sectional view through line 1C-1C of FIG. 1.

FIG. 1D is a schematic diagram of the distal end of another embodiment of a deflectable guide catheter of the present invention wherein the guide catheter is equipped with more than one pull member so that it may be deflected in more than one direction.

FIG. 2 is a perspective view of another embodiment of a deflectable 20 guide catheter of the present invention in combination with an endoscope system that that may be attached to and used in conjunction with any of the deflectable guide catheters of this invention.

FIG. 3 is a perspective view of another embodiment of a deflectable guide catheter of the present invention.

FIG. 3A is a partial, cut-away view of the proximal assembly of the deflectable guide catheter of FIG. 3.

FIGS. 4A through 4C are partial, schematic diagrams of the distal end of another embodiment of a deflectable guide catheter of the present invention in different states of deflection.

FIG. 5 is an anatomical diagram of the head of a human subject showing certain paranasal anatomical structures, a deflectable guide catheter of the present invention positioned adjacent to the ostium of the left maxillary sinus and a guidewire advanced through the guide catheter and into the left maxillary sinus.

FIGS. 6A through 6C show steps in a method by which the deflectable guide catheter shown in FIG. 5 may be inserted and positioned adjacent to the ostium of the left maxillary sinus without removal or substantial modification of normal anatomical structures.

FIG. 7 shows a dilator including a balloon.

FIG. 8 shows a balloon catheter comprising a balloon having an outer coating of diagnostic or therapeutic agents.

FIGS. 8A-8C show the steps of a method of using the balloon catheter of FIG. 18 to dilate an anatomical region.

FIGS. 9A-9F depict schematic diagrams showing steps in a procedure for a) access to and enlargement of the ostium of a paranasal sinus and b) implantation of an implantable substance delivery device of the present invention within the enlarged ostium and paranasal sinus.

DETAILED DESCRIPTION

The following detailed description and the accompanying drawings are intended to describe some, but not necessarily all, examples or embodiments of the invention. The contents of this detailed description and the accompanying drawings do not limit the scope of the invention in any way.

FIGS. 1 through 1C show one embodiment of a deflectable transnasal guide catheter device 10 of the present invention. In this embodiment, the guide catheter device 10 generally comprises an elongate catheter shaft 12 having a lumen 23, a deflectable distal portion 14 adjacent to is distal end DE and a proximal assembly 16 on its proximal end PE. As seen in FIGS. 1A and 1B, the catheter shaft 12 may be constructed of a substantially rigid tube 20, a deflector member which in this example is a helical spring member 30, a tubular inner jacket 24, an outer jacket 28 and, in some embodiments, an optional inner liner 26. In some embodiments, an energy guide such as a fiberoptic laser guide or wire for delivering current may extend through or replace the lumen 23.

The substantially rigid tube 20 has a lumen, an inner surface, an outer surface and a distal end and may be formed of malleable material including metals such as stainless steel hypotube. In the particular transnasal 30 embodiment shown, this substantially rigid tube 20 may be formed of hypotube having an outer diameter of about 2 mm to about 4 mm. The helical spring member 30 may be connected to the distal end of the substantially rigid tube 20 by solder, adhesive, a weldment or any other appropriate attachment member or substance 34, as seen in FIG. 1B. The helical spring member may alternatively comprise a section of the substantially rigid tube 20 in which a helical cut or one or more other cut(s), groves, openings, or weakened area(s) is/are formed. In some embodiments, the helical spring member may be formed of metal wire having a diameter of from about 0.016 inch to about 0.017 helically wound to a pitch of from about 0.060 inch to about 0.100 inch. In catheters sized for transnasal use, such helical spring member may also have a length of from about 0.625 inch to about 0.75 inch and an outer diameter of from about 0.100 inch to about 0.156 inch. The tubular inner jacket 24 has an inner surface, an outer surface and a lumen. This tubular inner jacket 24 may be formed of any suitable elastomer or other material, such as polyurethane, and may comprise a separate tube that is mounted on or fused in place or a coating or layer or material that has been applied by a suitable procedure such as dip coating, vapor deposition, painting, etc. In the particular non-limiting example shown in FIG. 1B, the tubular inner jacket 24 extends through the lumen of the substantially rigid tube 20 and, through the helical spring member 30, protruding slightly beyond the distal end of the spring member 30. A pull member 22, such as metal wire, monofilament or other suitable material, extends between the inner surface of the substantially rigid tube 20 and the outer surface of the tubular inner jacket 24. Such pull member 22 further extends through the spring member 30 and is connected to the distal end of the spring member 30 by solder, adhesive, weldment or any other appropriate attachment member or substance 34 and/or by tying, looping or twining the pull member around the wire, strand or other member of which the helical spring member 30 is formed. An outer jacket 28, such as an elastomeric (e.g., polyurethane) tube, may be disposed over the outer surface of the spring member 30 and, optionally, may extend in the distal direction to cover some or all of the outer surface of the substantially rigid tubular member 20. In the particular non-limiting example shown in FIGS. 1-1C, the outer jacket 28 extends proximally over the distal 3 cm to 5 cm of the substantially rigid tubular member 20. This outer jacket 28 may comprise a tube that is heat shrunk or otherwise caused to fight snuggly on the distal portion of the device 10. Alternatively, this outer jacket 28 may comprise be fused (e.g., heat fused), adhered by adhesive, solvent welded or otherwise affixed (e.g., sewn, stitched, etc.) to at least a portion of the inner jacket 24. For example, during manufacture, a mandrel may be inserted into the distal end of the device lumen 23 and heat may be applied to cause the outer jacket to heat shrink and to fuse at least its distal end to at least the distal end of the inner jacket 24. In some cases, the heating process may cause the inner jacket 24 and outer jacket 28 to melt or fuse together over the length of the spring member 30, substantially filling the helical space within the spring member 30 with elastomeric material as seen in FIG. 1B. Alternatively, as explained above, the outer jacket 28 may comprise a layer of material (e.g., polymeric coating material) that has been applied by a suitable process such as dip coating, vapor deposition, painting, etc. to form the outer jacket 28, as shown.

Optionally, in some embodiments, a tubular inner liner 26 such as a thin walled polytetrafluoroethylene (PTFE) tube may extend through all or part of the lumen 23 of the device. Such inner liner 26 (if present) may or may not be fused (e.g., heat fused), adhered by adhesive, solvent welded or otherwise affixed to all or part of the inner jacket 24.

In operation, when the pull member 22 is pulled in the proximal direction, the curvature of the spring member 30 (and the curvature of the deflectable distal portion 14) will increase. Conversely, when the pull member is advanced in the distal direction, the curvature of the spring member 30 (and the curvature of the deflectable distal portion 14) will decrease. In embodiments intended for transnasal insertion and use in accessing the ostia or paranasal sinuses, it is desirable for the distal portion 14 to be deflectable to form curves ranging from about 0 degrees (i.e., substantially straight) to at least about 110 degrees. As will be explained in more detail herebelow, the deflection of the distal portion 14 may be carried out before and/or after the distal portion has been inserted into the body of a human or animal subject.

In some embodiments, the proximal and distal movement of the pull member 22 may be controlled by a deflection control that is located on a portion of the guide catheter device 10 that remains outside of the subject's body. In the particular embodiment of the guide catheter device 10 shown in FIGS. 1-1C, this deflection control comprises a control knob 48 located on the proximal assembly 16. As seen in detail in FIG. 1C, this proximal assembly 16 comprises an externally threaded two-piece body member 46 having a female Luer fitting 40 at its proximal end, the control knob 48 having internal threads that are mated with the external threads of the inner body member 46. Spring 47 applies tension on Luer fitting 40 and liner 26 with respect to body member 46. Pull member 22 is connected to a washer that is in contact with body member 46. When the control knob 48 is rotated in one direction (e.g., clockwise), it advances in the distal direction causing the body member 46 and the pull member 22 to also advance in the distal direction and resulting in a decrease of the curvature of the deflectable distal portion 14. When the control knob 48 is rotated in the opposite direction (e.g., counterclockwise), it retracts in the proximal direction causing the body member 46 and the pull member 22 to also retract in the proximal direction and resulting in an increase in the curvature of the deflectable distal portion 14.

Also, in some embodiments, indicia (e.g., markings, graduations, zones, projections, other visible or tactilely discernable indicators) may be associated with the deflection control to indicate to the operator the present direction and/or degree of curvature of the deflectable distal portion 14. Such indicia may be located on a portion of the device that remains outside of the subject's body to enable the operator to determine the direction or plane in which the deflectable distal portion 14 will curve and/or the degree to which it is presently curved, even though the deflectable distal portion 14 may be located within the subject's body and out of the operator's sight. In the particular embodiment of the guide catheter device 10 shown in FIGS. 1-1C, diametrically opposed wings 42 may extend radially from the proximal assembly 16 in a plane that is the same as or parallel to a plane in which the deflectable distal portion 14 curves, thereby acting as indicia of the direction or plane in which the deflectable distal portion 14 will curve. Also, graduation markings (not shown) may be formed on the proximal assembly 16 to indicate how far the control knob 48 is advanced in the distal direction and the corresponding degree of curvature of the distal portion 14 (e.g., in some embodiments markings may be formed at increments between 0 degrees and approximately 110 degrees, etc.).

FIG. 1D shows an embodiment of a guide catheter device 10 a of the present invention that is essentially the same as that shown in FIGS. 1A-1C, but which includes two pull members 22 a, 22 b (and may have two deflection controls) to cause the deflectable distal portion 14 a of the catheter shaft 12 a to deflect in two directions, as shown. It will be appreciated that any of the deflectable guide catheters of the present invention may have a single pull member 22 such that they may be deflectable in a single direction or they may have a plurality of pull members 22 a, 22 b such that they may alternately be deflected in different directions.

FIG. 2 shows another embodiment of a guide catheter 10 b of the present invention that is essentially the same as that shown in FIGS. 1-1C, but wherein the proximal assembly 16 b comprises a handpiece body 52 and wherein the deflection control comprises a rotatable wheel 54 mounted on the handpiece 52. Rotatable wheel 54 is linked to the pull member (not seen in FIG. 2) such that when the wheel 54 is rotated in one direction (e.g., clockwise), it will cause the pull member 22 to advance in the distal direction resulting in a decrease of the curvature of the deflectable distal portion 14 b of shaft 12 b. When the wheel 54 is rotated in the opposite direction (e.g., counterclockwise), it causes the pull member 22 to retract in the proximal direction thereby resulting in an increase in the curvature of the deflectable distal portion 14 b of shaft 12 b.

Also, the showing of FIG. 2 includes an optional endoscope system 50 that may be attached to or integrated with any deflectable guide catheter of this invention such that the guide catheter device may be used in conjunction with an endoscope system 50. This endoscope system 50 comprises a flexible endoscope 60, such as a fiberoptic scope, that is attached to the shaft 12 b of the guide catheter device 10 b by way of connectors 56, 57, 58 such as clips, bands, snap-in grooves, etc. In some embodiments, the connectors 56, 57, 58 may be constructed to allow the endoscope 60 to be longitudinally advanced and retracted relative to the shaft 12 b of the guide catheter 10 b. The endoscope 60 is connected to a camera 62 and the camera 62 is connectable by way of camera cable 64 to a monitor on which an image received through the endoscope 60 may be displayed. Each endoscope 60 has a particular field of view. In this system, the vantage point of the endoscope 60 may be moved by varying the degree of deflection of the deflectable distal portion 14 b of the shaft 12 b, thus bringing different anatomical structures and/or anatomical areas within the endoscope's field of view. Also, in embodiments where the endoscope 60 is advanceable, the degree of curvature of the deflectable distal portion 14 b may be changed to guide the advancement of the endoscope as desired. For example, if it is desired to cause the endoscope to advance through the ostium of a paranasal sinus and into the sinus cavity, the operator may position the distal end DE of the guide catheter 10 b near the ostium, visualize the ostium with the scope, and then alter the curvature of the deflectable distal portion 14 b as the endoscope 60 is advanced, thereby guiding the endoscope 60 into the ostium as desired. Also, in some applications, such as when it is desired to pass a guidewire or other device through the frontal outflow tract and into a frontal sinus, the operator may be faced with confusing anatomy, such as the presence of one or more false or blind openings in addition to the actual opening through which the guidewire or device is intended to pass. In such instances, the optional endoscope 60 may be used to assist the operator in serially or systematically probing or identifying each available opening, thereby facilitating identification of the correct opening and simplifying passage of the guidewire or device into the correct passage. Examples of endoscopes that may be used in this system include those described in U.S. patent application Ser. No. 11/803,695 entitled “Endoscopic Methods And Devices For Transnasal Procedures” filed May 14, 30 2007, issued as U.S. Pat. No. 9,554,691 on Jan. 31, 2017; Ser. No. 11/647,530, entitled Endoscopic Methods and Devices for Transnasal Procedures filed Dec. 27, 2006, published as U.S. Pub. No. 2007/0167682 on Jun. 19, 2007, now abandoned; Ser. No. 11/725,151 entitled Endoscopic Methods and Devices for Transnasal Procedures filed Mar. 15, 2007, issued as U.S. Pat. No. 9,089,258 on Jun. 28, 2015, and U.S. Provisional Patent Application No. 60/844,874 entitled Endoscopic Methods and Devices for Transnasal Procedures filed Sep. 15, 2006, the entire disclosures of such patent applications being expressly incorporated herein by reference.

FIGS. 3 and 3A show an embodiment of a deflectable guide catheter 10 c which is essentially the same as that shown in FIGS. 1-1C, except that the proximal assembly 16 c comprises a handpiece body having a rotatable thumb wheel 64 that rotates about an axis that is perpendicular to the longitudinal axis of the catheter shaft 12 c. This rotatable thumb wheel 64 is linked to the pull member (not seen in FIG. 3) such that when the thumb wheel 64 is rotated in one direction (e.g., forward), it will cause the pull member 22 to advance in the distal direction resulting in a decrease of the curvature of the deflectable distal portion 14 c of shaft 12 c. When the thumb wheel 64 is rotated in the opposite direction (e.g., back), it causes the pull member 22 to retract in the proximal direction thereby resulting in an increase in the curvature of the deflectable distal portion 14 c of shaft 12 c. As seen in FIG. 3, the thumb wheel 64 may extend in a plane and/or direction that is the same or parallel to the plane and/or direction in which the deflectable distal portion 14 c will curve, thereby acting as indicia of the direction and/or plane of curvature. Additionally, as seen in the cut away view of FIG. 3A, indicia of the degree to which the deflectable distal portion 14 c is presently curved may be provided on the thumb wheel 64. For example, three colored zones 66, 68, 70 may be formed on the thumb wheel 64. A first (e.g., white) zone 66 may be visible and aligned with a mark on the handpiece when the deflectable portion 14 c is curved from about 0 degrees (i.e., substantially straight) to about 36.6 degrees, a second (e.g., red) zone 68 may be visible and aligned with a mark on the handpiece when the deflectable portion 14 c is curved from about 36.7 to about 73.2 degrees and third (e.g., blue) zone 70 may be visible and aligned with a mark on the handpiece when the deflectable portion 14 c is curved from about 73.3 degrees to about 110 degrees. It is to be appreciated that may other types of indicia (e.g., hash marks or graduations by degree) may be employed as an alternative to the colored zones 66, 68, 70 shown in FIG. 3A.

As those of skill in the art will appreciate, deflection mechanisms known in the art, other than those described in these examples, may alternatively be used in any of the deflectable catheters of this invention, including but not limited to: slides, triggers, hydraulics, electromagnetic field activation, shape memory materials which respond to current or temperature change, a straight stylet that is insertable into a catheter that is biased to a curved configuration to overcome a curve bias thereby straightening the catheter, a curved stylet that that is insertable into a catheter that is biased to a straight configuration to cause the catheter to assume a curved shape, etc.

FIGS. 4A through 4C show another embodiment of a deflectable guide catheter 10 d which may be substantially the same as that shown in FIGS. 1-1C, but wherein the deflectable portion 14 d of shaft 12 d includes a proximal segment 70 having a beveled distal end, a rotatable medial segment having beveled proximal and distal ends and a rotatable distal segment 74 having a beveled proximal end. The beveled proximal end of the medial segment 72 abuts against the beveled distal end of the proximal segment 70. The beveled distal end of the medial segment 72 abuts against the beveled proximal end of the distal segment 74. Rotation of the medial segment 72 by 180 degrees causes the deflectable portion 14 d to change from the straight configuration seen in FIG. 4A to the partially curved configuration seen in FIG. 4B. Thereafter, rotation of the distal segment by 180 degrees causes the deflectable portion 14 d to change from the partially curved configuration seen in FIG. 4B to the fully curved configuration seen in FIG. 4C. It will be appreciated that this embodiment will not include a pull wire 22. Rather, the operator may rotate the medial and/or distal segments 72, 74 by hand before the guide catheter device 10 d is inserted into the subject's body. Alternatively, a rotational deflection control mechanism may be provided on a portion of the device that remains outside of the body and linked to the medial and/or distal segments 72, 74 so as to enable the operator to selectively rotate the medial and/or distal segments 72, 74 after the deflectable portion 14 d of the device has been inserted into the subject's body.

The deflectable guide catheters 10, 10 a, 10 b, 10 c, 10 d of this invention may be used to guide the insertion of a wide variety of devices to a variety of locations within the body. In one non-limiting example shown in FIGS. 5 and 6A-6C, the embodiment of the deflectable guide catheter 10 shown in FIGS. 1-1C is used to introduce a guidewire GW into the left maxillary sinus MS of a human subject. After the guidewire has been advanced in to the maxillary sinus MS, one or more other devices (e.g., catheters, scopes, electrodes, dilators, substance delivery implants, stents, etc.) may be advanced over the guidewire and/or through the lumen 23 of the guide catheter 20. FIG. 7 shows a dilator 100 including a balloon 100, which may be advanced over the guidewire to dilate an opening or anatomical passageway, such as the opening of a paranasal sinus. Although this particular example shows a procedure involving the maxillary sinus MS, it is to be appreciated that this is merely one example and is not intended to provide an exhaustive description of all possible procedures that may be performed using the deflectable guide catheters of this invention. Indeed, as will be well understood by persons of skill in the art, the deflectable guide catheters of this invention may be used to access the ostia of any paranasal sinuses (frontal, sphenoid, maxillary) or other passageways (e.g., openings that have been formed into the ethmoid air cell(s) or other sinuses, Eustachian tubes, naso-lacrimal ducts, etc.) and/or many other locations within the ear, nose or throat.

As seen in FIG. 6A, the deflectable distal portion 14 of the guide catheter 10 is initially disposed in a configuration that is substantially straight (e.g., about 0 degrees of curvature). The guide catheter shaft 12 is inserted distal end first into the subject's left nostril with the catheter shaft 12 orientated such that, when subsequently deflected, the deflectable portion 14 will curve in the lateral direction. The catheter shaft is advanced through the middle meatus MM along the lateral aspect of the middle turbinate MT until the deflectable portion 14 has passed the protruding uncinate process. Thereafter, the operator will rotatably retract the control knob 48 causing the deflectable portion 14 to curve to a configuration wherein the distal end DE of the catheter shaft 12 is directed toward the maxillary sinus ostium MSO as seen in FIG. 6B. For entry into the maxillary sinus ostium in a subject whose who's anatomy in this area has not been altered by prior surgery, the deflectable portion 14 will be deflected to a curve of about 90 degrees to about 110 degrees. An x-ray, fluoroscope, embedded navigation sensor useable with an image guided surgery system, the optional attached endoscope 60 (if present) or a separate endoscope (if inserted) may be used to verify that the curvature, orientation and position of the guide catheter 10 is as desired. Thereafter, the guide catheter shaft 12 may be moved in the lateral direction causing the distal end DE of the guide catheter shaft 12 to advance around the intact uncinate process UN to a location within or near the maxillary sinus ostium MSO. Thereafter, the guidewire GW is advanced through the lumen 23 of the guide catheter 10 and into the maxillary sinus MS as seen in FIG. 5. Similar procedures (but different curvatures of the deflectable portion 14) may also be used to facilitate placement of the distal end DE of the guide catheter within or adjacent to the ostia of the frontal, sphenoid or ethmoid sinuses, within or adjacent to other openings such as that of the naso-lacrymal duct or Eustachian tube and/or adjacent to man-made openings (e.g., ethmoidectomy or othmoidotomy openings into ethmoid air cells, openings into the cranium to access anatomical structures such as the pituitary gland, etc.

The deflectable guide catheters 10, 10 a, 10 b, 10 c, 10 d of this invention may provide a number of advantages over the use of guide catheters having fixed shapes. For example, the guide catheters 10, 10 a, 10 b, 10 c, 10 d of this invention may be inserted and advanced through the nasal anatomy while in a first configuration (e.g., straight or only slightly curved) thereby allowing the distal portion of the guide catheter to easily advanced though narrow or constricted regions of anatomy and/or adjacent to other devices (e.g., an endoscope) may also be inserted into the nose. Thereafter, after the guide catheter has been advanced to a desired location, the guide catheter may be deflected to a second configuration (e.g., a substantially curved shape) thereby causing or allowing the distal opening of the guide catheter 10, 10 a, 10 b, 10 c, 10 d to move into a position that is adjacent to an in alignment with a desired sinus ostium or passageway so that the intended substance or device may be delivered through the guide catheter lumen and into or through that ostium or passageway. Thereafter, the guide catheter 10, 10 a, 10 b, 10 c, 10 d may then be returned to the first configuration (e.g., straight or only slightly curved) to facilitate its withdrawal and removal from the anatomy. In this manner, the deflectable guide catheters 10, 10 a, 10 b, 10 c, 10 d of the present invention may be easier to insert/remove and may be less traumatic to the anatomy than other guide catheters having a fixed shapes. Also, when used for some procedures (e.g., balloon dilation of a paranasal sinus ostium) the deflectable guide catheters 10, 10 a, 10 b, 10 c, 10 d of the present invention may result in faster procedure times (e.g., no need to remove balloon and guidewire from the guide catheter on one side of the nostril). Additionally, the deflectable guide catheters 10, 10 a, 10 b, 10 c, 10 d of the present invention may allow hospitals, surgical centers, surgeon's offices or other locations where these procedures are performed to maintain less inventory, as a single deflectable guide catheter bay be used to replace a number of fixed shape guide catheters used in the prior art (e.g., sinus guide catheters having fixed angles of 0, 30, 70, 90 and 110 degrees may be replaced by a single deflectable guide catheter that is capable of being deflected to angles ranging from 0 to 110 degrees.).

As described in U.S. patent application Ser. No. 11/037,548 (now U.S. Pat. No. 7,462,175), the disclosure of which has already been incorporated by reference herein, FIG. 8 shows a balloon catheter comprising a balloon having an outer coating of diagnostic or therapeutic agents. Balloon catheter 1700 comprises a shaft 1702 and a dilating balloon 1704 located on the distal region of shaft 1702. Dilating balloon 1704 can be made of suitable non-compliant materials e.g. polyethylene terephthalate etc. Dilating balloon 1704 comprises a coating 1706 of one or more diagnostic or therapeutic agents on the outer surface of dilating balloon 1704. Coating 1706 may comprise diagnostic or therapeutic agents located in a suitable carrier medium. In one embodiment, the carrier medium is a hydrogel. In another embodiment, the carrier medium is a solid having the consistency of wax e.g. sterile bone wax. In another embodiment, the carrier containing the agents can be deposited on the outer surface of dilating balloon 1704 just before balloon catheter 1700 is used for performing a diagnostic or therapeutic procedure. Coating 1706 may be present on the surface of dilating balloon 1704 in a variety of configurations. In one embodiment, coating 1706 is in the form of parallel strips of a carrier medium comprising one or more diagnostic or therapeutic agents. The coating may also be in the form of an annular layer, a plurality of discrete spots etc. When dilating balloon 1704 is inflated to dilate an anatomical region, coating 1706 comes into contact with the adjacent anatomical region. A portion of coating 1706 is deposited on the adjacent anatomical region which delivers the diagnostic or therapeutic agents to the adjacent anatomical region. Thus dilation and agent delivery can be achieved in a single step. In one embodiment, coating 1706 comprises a hemostatic material with a consistency of bone-wax.

FIGS. 8A-8C show the steps of a method of using the balloon catheter of FIG. 18 to dilate an anatomical region. In FIG. 8A, balloon catheter 1700 is introduced in an anatomical region 1708. Balloon catheter 1700 is positioned such dilating balloon 1704 is located in the target region to be dilated. Thereafter, in FIG. 8B, dilating balloon 1704 is inflated. This dilates anatomical region 1708 and deposits a portion of coating 1706 on the dilated region. Thereafter, in FIG. 8C, dilating balloon 1704 is deflated and balloon catheter 1700 is withdrawn from anatomical region 1708 leaving behind a deposited layer 1710 of coating 1706 on the dilated anatomical region 1708.

Similarly, as described in U.S. patent application Ser. No. 10/912,578 (now U.S. Pat. No. 7,361,168), the disclosure of which has already been incorporated by reference herein, FIGS. 9A-9F show one of many possible examples of procedures that may be performed using the implantable substance delivery devices of the present invention. This particular example shows a method for treating sinusitis in a human or animal subject. In this subject, the sinusitis is due at least in part to impaired drainage from the sinus as a result of an occlusion of the ostium OS that leads into the paranasal sinus. The ostium OS consists of thin bone B covered by mucosal tissue. As shown in FIG. 9A, a guidewire such as a Guidant Hi-Torque Supracore 35 Guide Wire is advanced through the ostium OS and into the paranasal sinus. As shown in FIG. 9B, a balloon catheter 200 such as the Guidant Agiltrac 0.035 Peripheral Dilatation Catheter having a balloon 202 formed of relatively strong material such as polyethylene teraphthalate is then advanced over the guidewire GW to a position where the balloon 202 is positioned within the ostium OS. Thereafter, as shown in FIG. 9B, the balloon 202 is inflated so as to dilate the ostium OS possibly breaking bone B that surrounds the ostium OS and creating an enlarged ostium EOS. Thereafter, as shown in FIG. 9C, the balloon 202 is deflated and the balloon catheter 200 is withdrawn and removed, leaving the guidewire GW in place. Thereafter, a delivery catheter of any of the type described herein is advanced over the guidewire GW and to deliver an empty implantable substance delivery device 12 i of the present invention within the enlarged ostium EOS such that a portion of the device 12 i extends into the sinus, as shown in FIG. 9E. In this example, the implantable substance delivery device 12 i is an over the wire type device 12 i having a fill tube 204, an intraostial portion 206 which includes a self-expanding frame 208 and intrasinus portion 210. As shown in FIG. 9F, after the implantable substance delivery device 12 i has been positioned such that its intraostial portion is within the enlarged ostium EOS and its intrasinus portion is within the paranasal sinus, the delivery catheter and guidewire GW are removed and a quantity of the desired diagnostic or therapeutic substance (e, g, a corticosteroid, anti-inflammatory, antimicrobial, mucous modifying or mucolytic agent, or other agent or substance effective to treat sinusitis) is infused through the fill tube 204 into the device 12 i. As shown in FIG. 9F, this causes the intrasinus portion 210 of the device 12 i to swell or expand to an enlarged configuration that will not pass out of the enlarged ostium EOS. Also, the intraostial portion 206 and frame 208 will enlarge to an expanded configuration that exerts outward radial pressure against the enlarged ostium EOS for a period of time sufficient to allow the enlarged ostium OS and any broken bone BB therein to heal and remodel to the enlarged diameter. Also, the substance(s) that was/were introduced into the device 12 i will diffuse out of the device 12 into the sinus at a desired rate, thereby providing pharmacological treatment for the infection, inflammation and/or other aspects of the sinusitis. Thereafter the device 12 i may biodegrade and/or may be removed and the enlarged ostium will remain facilitating normal drainage from the sinus thereafter.

It is to be appreciated that the invention has been described hereabove with reference to certain examples or embodiments of the invention but that various additions, deletions, alterations and modifications may be made to these examples and embodiments without departing from the intended spirit and scope of the invention. For example, any element or attribute of one embodiment or example may be incorporated into or used with another embodiment or example, unless otherwise indicated or unless doing so would render the embodiment or example unsuitable for its intended use. Also, where the steps of a method or procedure are referred to or listed in a specific order, the order of such steps may be changed unless otherwise specified or unless doing so would render the method or procedure unsuitable for its intended use. All reasonable additions, deletions, modifications and alterations are to be considered equivalents of the described examples and embodiments and are to be included within the scope of the following claims. 

1. (canceled)
 2. An apparatus comprising: (a) a catheter shaft, the catheter shaft being configured to fit in a nasal cavity of a patient; (b) a balloon positioned at a distal end of the catheter shaft, the balloon being configured to transition between a non-inflated state and an inflated state, the balloon in the non-inflated state being configured to fit in a passageway associated with a nasal sinus cavity, the balloon in the inflated state being configured to dilate the passageway associated with the nasal sinus cavity; and (c) a coating on the balloon, the coating including a therapeutic agent, the therapeutic agent being configured to provide a therapeutic effect on tissue in or near the passageway associated with the nasal sinus cavity.
 3. The apparatus of claim 2, the balloon being formed of a non-compliant material.
 4. The apparatus of claim 3, the balloon comprising polyethylene.
 5. The apparatus of claim 2, the coating further including a carrier medium for the therapeutic agent.
 6. The apparatus of claim 5, the carrier medium including hydrogel.
 7. The apparatus of claim 2, the coating being arranged in a plurality of strips on the balloon.
 8. The apparatus of claim 2, the coating being arranged in an annular layer on the balloon.
 9. The apparatus of claim 2, the coating being arranged in a plurality of discrete spots on the balloon.
 10. The apparatus of claim 2, the therapeutic agent including a hemostatic material.
 11. The apparatus of claim 2, further comprising a guidewire, the catheter shaft being configured for advancement along the guidewire.
 12. The apparatus of claim 2, further comprising a frame disposed about the balloon.
 13. The apparatus of claim 12, the frame being configured to self-expand.
 14. The apparatus of claim 2, the balloon being configured to diffuse the therapeutic agent to thereby provide the coating.
 15. An apparatus comprising: (a) a catheter shaft, the catheter shaft being configured to fit in a nasal cavity of a patient; (b) a balloon positioned at a distal end of the catheter shaft, the balloon being configured to transition between a non-inflated state and an inflated state, the balloon in the non-inflated state being configured to fit in a passageway associated with a nasal sinus cavity, the balloon in the inflated state being configured to dilate the passageway associated with the nasal sinus cavity; and (c) a therapeutic agent carried by the balloon, the therapeutic agent being configured to provide a therapeutic effect on tissue in or near the passageway associated with the nasal sinus cavity.
 16. The apparatus of claim 15, the therapeutic agent being carried on the balloon as a coating on the balloon.
 17. The apparatus of claim 15, the balloon defining an interior, the interior being configured to receive the therapeutic agent, the balloon being configured to diffuse the therapeutic agent from the interior.
 18. A method comprising: (a) inserting a balloon catheter into a nasal cavity of a patient; (b) positioning a balloon of the balloon catheter in a passageway associated with a nasal sinus of the patient; (c) expanding the balloon to thereby dilate the passageway; and (d) delivering a therapeutic agent to the passageway via the expanded balloon.
 19. The method of claim 18, the passageway including a sinus ostium.
 20. The method of claim 18, the therapeutic agent including a steroid.
 21. The method of claim 18, the balloon including a coating containing the therapeutic agent, the therapeutic agent being delivered via contact between the balloon and tissue of the passageway. 